Jan 30- The U.S. Food and Drug Administration is asking manufacturers of a common opioid medicine to change the way the drug is packaged, as part of efforts to deter its abuse amid an opioid epidemic in the United States. The FDA said on Tuesday it sent letters to manufacturers of diarrhea medicine loperamide, asking them to ensure that packages contain only a...

Jan 29- Japan's Takeda Pharmaceutical Co Ltd said on Monday the U.S. Food and Drug Administration had granted' fast track' status to its vaccine for the mosquito-borne Zika virus, which erupted as a major public hazard in Brazil three years ago. The virus might be responsible for an increase in birth defects in the United States and its territories, the U.S. Centers...

Jan 26- The U.S. Food and Drug Administration on Thursday approved a radioactive drug to treat the ultra-rare type of digestive tract cancer that killed Steve Jobs in 2011.. The approval for Advanced Accelerator Applications SA's Lutathera comes just days after Swiss giant Novartis AG closed its $3.9 billion acquisition of the French company.

Jan 26- The U.S. Food and Drug Administration on Thursday approved a therapy for a rare type of digestive tract cancer that killed Apple co-founder Steve Jobs in 2011.. The approval for the drug made by French drugmaker Advanced Accelerator Application SA comes three months after Swiss giant Novartis AG agreed to buy the company for $3.9 billion.

Jan 26- The U.S. Food and Drug Administration on Friday approved French drugmaker Advanced Accelerator Application SA's drug to treat patients with a type of digestive tract cancer. The FDA said the drug, Lutathera, was approved to treat a type of cancer affecting a gastrointestinal tract. Swiss biotech Novartis AG agreed in October to buy Advanced Accelerator...

ZURICH, Jan 26- Fears U.S. "The U.S. Food and Drug Administration wants to trim the time it takes for drugs to be approved," Christoph Franz told Swiss newspaper Blick in an interview published on Friday. "Fears that Trump would damage the pharmaceuticals branch have not been realised," Franz, who was in Davos for the World Economic Forum meeting, told Blick in the...

WASHINGTON, Jan 25- Philip Morris International Inc should not be allowed to claim that its iQOS electronic tobacco device can reduce the risk of tobacco-related diseases compared with cigarettes, an advisory panel to the U.S. Food and Drug Administration said on Thursday. IQOS is used by nearly 4 million people in 30 markets outside the United States but needs...

WASHINGTON, Jan 25- Philip Morris International Inc should not be allowed to claim that its iQOS electronic tobacco device can reduce the risk of tobacco-related diseases, an advisory panel to the U.S. Food and Drug Administration concluded on Thursday. The FDA is expected to decide whether Philip Morris can sell iQOS within the next few months.

Jan 25- Philip Morris International Inc should not be allowed to claim that its iQOS electronic tobacco device can reduce the risks of tobacco-related diseases for smokers who completely switch from cigarettes, a U.S. Food and Drug Administration advisory panel concluded on Thursday. The panel voted 8-0 with one abstention that the company has not...

WASHINGTON, Jan 24- Philip Morris International Inc told a U.S. advisory panel on Wednesday that it expects around 6 million smokers to switch completely to its iQOS electronic tobacco device if the company is allowed to claim it is less risky than cigarettes. The company hopes to convince the U.S. Food and Drug Administration advisory panel that the product...

Still, their combined sales are expected to fall more than 40 percent by 2022, according to consensus analyst forecasts compiled by Thomson Reuters. The U.S. Food and Drug Administration approved Mylan NV's biosimilar of Herceptin last month. The FDA and the European Commission have both approved Amgen's biosimilar version of Avastin.

The review comes two days before a meeting of outside advisors to the FDA who will discuss the product and recommend whether it should be allowed on the market. That is in part because the FDA under Commissioner Scott Gottlieb has committed to a tobacco policy that relies on the availability of reduced-risk products to help smokers obtain nicotine in a less...

The review comes two days before a meeting of outside advisors to the FDA who will discuss the product and recommend whether it should be allowed on the market. The FDA is not obliged to follow the recommendations of its advisors, but typically does. The FDA reviewers found that by some respiratory and cardiovascular measures, iQOS aerosol exposure produced...

Jan 22- An electronic tobacco product made by Philip Morris International Inc that heats rather than burns tobacco contains lower levels of harmful and potentially harmful compounds than cigarettes, a preliminary review by the U.S. Food and Drug Administration concluded on Monday. Laboratory data showed that the aerosol produced by the product, iQOS, can...

The announcement was one of several by the FDA on Thursday regarding its priorities in 2018 for drug compounding, which involves pharmacists making drugs to meet patients' specific needs. Gottlieb said the FDA is also preparing a new policy to give state boards of pharmacy more flexibility to oversee compounding pharmacies that ship drugs interstate and is...

The move follows a dispute between the FDA and the defense department over a provision in the annual defense authorization bill that would have allowed the Pentagon to authorize the emergency use of drugs and medical devices that have not been approved by the FDA. The U.S. Senate and House of Representatives ultimately passed a bill leaving authority to...

Jan 16- The U.S. Food and Drug Administration and Department of Defense launched a program on Tuesday to speed up the development of drugs that could be used by military personnel. The move follows a controversy over whether the Pentagon should be allowed to authorize the emergency use of drugs and medical devices that have not been approved by the FDA.

Jan 16- Eiger BioPharmaceuticals Inc said on Tuesday it would stop development of its blood pressure drug after it failed in a mid-stage study, sending its shares plunging about 46 percent. There are no U.S. Food and Drug Administration- approved drugs to cure the condition, but it can be managed with treatments available in the market. "We have always recognized...